Table 3. Real world evidence on lorlatinib in ALK+ve advanced NSCLC.
| Author | N | Use of lorlatinib | Prior TKI | CNS metastasis | ORR | AE | Median PFS | Median OS |
|---|---|---|---|---|---|---|---|---|
| Orlov et al [15] | 35a | Second line – 16 Third line – 12 Fourth line – 5 |
Crizotinib – 17 Ceritinib – 17 Alectinib – 2 |
27 | 43% | 89% | 21.8 months | 70.1 months |
| Alexander et al [16] (LOREALAUS) | 38 | Second line – 15 Third line – 13 Fourth line – 5 Later line – 5 |
First gen TKI – 12 Second gen TKI – 20 |
19 | 44% | 60%b | 7.3 monthsc; 13.2 monthsd |
70 months |
| Zhu et al [17] | 76 | Second line – 7 Third line – 18 Fourth line – 19 Later line – 32 |
Crizotinib – 66 Ceritinib – 46 Alectinib – 43 Brigatinib – 10 Ensartinib – 1 |
64 | 33% | ~70% | 9.3 months | Not reached |
| Talreja et al [22] | 34 | Second line – 0 Third line – 18 Fourth line – 11 Later line – 5 |
Crizotinib – 34 | Not reported | 56% | 94% | 9.6 months | 53.5 months |
| Lee et al [18] | 10 | Third line – 10 | Crizotinib – 10 Ceritinib – 7 Alectinib – 2 Brigatinib – 1 |
7 | 67% | 83% | 6.5 months | Not reached |
| Hochmair et al [19] | 37 | Second line – 10 Third line – 23 Fourth line – 13 Fifth line – 1 |
Crizotinib – 25 Ceritinib – 21 Alectinib – 14 Brigatinib – 27 |
19 | 43% | 49% | 4.4 monthse | 41.8 months |
| Goto et al [20] | 221 | Second line – 154 ≥Third line – 67 |
Alectinib – 221 Ceritinib – 38 |
Not reported | Not reported | Not reported | 5 monthse | Not reported |
| Peled et al [21] (GLASS) | 106 | Second line – 16 Third line – 40 Fourth line – 33 ≥Fourth line – 17 |
Crizotinib – 40 Ceritinib – 25 Alectinib – 15 Brigatinib – 13 |
72 | 60% | 46% | Not reached | 89.1 months |
| Current study (ROSELAND) | 38 | Second line – 11 Third line – 21 Fourth line – 4 ≥Fifth line – 2 |
Crizotinib – 33 Ceritinib – 25 Alectinib – 3 |
15 | 70% | 87% | Not reached | 93.1 months |
AE, adverse event; ALK, anaplastic lymphoma kinase; CNS, central nervous system; NSCLC, non-small cell lung cancer; ORR, overall response rate; OS, overall survival; PFS, progression free survival; TKI, tyrosine kinase inhibitor
a
Two patients received lorlatinib as first line use
b
23 patients had thromboembolic events. No details about any other toxicity
c
PFS in whole group
d
PFS in patients who received ≥30 days of lorlatinib
e
Median duration of therapy